BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER

    MDR report key: 2863491 · Received December 10, 2012

    Report

    Report Number
    8030965-2012-01476
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPOSITIONED ON (B)(4) 2012, NOT EXPLANTED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT . THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SYNFIX IMPLANT AT L4-L5 ON (B)(6) 2012. DURING THAT PROCEDURE, IT WAS NOTED THE INSERTER USED WAS NOT THE CORRECT INSERTER, RESULTING IN THE IMPLANT BEING IMPLANTED TOO DEEP. THE IMPLANT WAS REPOSITIONED TO THE CORRECT DEPTH AND THAT PROCEDURE WAS COMPLETED. PATIENT LATER COMPLAINED OF PAIN. CT SCAN TAKEN ON AN UNKNOWN DATE REVEALED BILATERAL BONE FRAGMENTS IN THE FORAMAN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR POSTERIOR LUMBAR FUSION, DECOMPRESSION, AND REMOVAL OF THE BONE FRAGMENTS. ORIGINAL IMPLANT REMAINS IMPLANTED. PATIENT WAS FUSED POSTERIORLY WITH PEDICLE SCREWS. THIS IS THE 1ST OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER SYNFIX(TM)-LR MAX SYNTHES GMBH 7972176

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention INSERTER